Celltrion Unveils Phase 1 Clinical Data of Actemra Biosimilar at EULAR

Posted on by Grayson

The following are excerpts from The Korea Economic Daily dated May, 31, 2023:

South Korean biosimilar giant Celltrion Inc. revealed on Wednesday the highly anticipated clinical phase 1 data for its Actemra biosimilar, CT-P47, at the 2023 European Congress of Rheumatology (2023 EULAR) conference.

The clinical data for CT-P47 was made available online by Celltrion, following a phase 1 study involving 318 health South Korean subjects. The company announced that it had successfully demonstrated pharmacodynamic (PK) equivalence and safety comparable to the original drug.

Click here to learn more.

Survey: Talking to HCPs and Access 2023

Survey: Talking to HCPs and Access

Posted on by Grayson

Back in 2016, I collected some initial information about how people felt they could talk to healthcare providers (HCPs) about sexual health and function, sexual orientation, and gender. Then, in the fall of 2019, I conducted a more extensive survey. I’m still working on the results of that survey.

With the changes occurring in the last few years, though, I wanted to collect information again. Allow me to introduce you to the new 2023 survey.

This survey asks the same questions as before, such as “Have any of your physicians or other healthcare providers talked to you about sex or sexual issues?” It also has a section about how recent anti-equity efforts, such as rampant transphobia, have affected these conversations.

This survey is open as of May 28, 2023, and will close at the end of the day on July 31, 2023. It is only open to US residents aged 18 and up.

Take the survey here.

Things Your Doctor Needs To Hear You Say

Posted on by Grayson

As patients, we often rely on doctors to provide us with the best possible care. However, it’s important to remember that our doctors are only able to help us to the extent that we communicate with them. There are certain things that doctors need to hear from their patients in order to provide the best possible treatment. Let’s explore some of the crucial things that you need to communicate to your doctor during your medical appointments. By doing so, you’ll be better equipped to receive the care you need to get closer to optimal health.

"Things Your Doctor Needs to Hear You Say" with a photo of a patient and a healthcare provider talking

My Symptoms Are Worse Than Usual

When you’re experiencing symptoms, it’s important to understand that managing them is an essential part of receiving appropriate medical care. Your doctor relies on you to provide accurate information about your symptoms, so they can adjust your treatment plan accordingly. Keeping your symptoms under control not only helps you feel better, it can also prevent complications and improve your quality of life.

It’s important to pay attention to your symptoms and recognize when they’re getting worse. This can include an increase in severity, frequency, or duration. Certain symptoms, like fever, pain, or shortness of breath, can also be a sign of a more serious condition. If you notice any changes in your symptoms, it’s important to bring it up with your doctor right away.

How to Accurately Describe Your Symptoms to Your Doctor

Describing your symptoms accurately is crucial for your doctor to make an accurate diagnosis and treatment plan. Try to be as specific as possible, including when your symptoms started, what makes them worse, what makes them better, and any other relevant details. Consider keeping a symptom diary to help you keep track of your symptoms and bring it with you to your appointments.

This can be a daunting task, but it’s an important step in receiving effective treatment. Take notes about your symptoms, including when they occur and how severe they are. Use descriptive words to help your doctor understand what you’re experiencing. Your doctor may also ask you specific questions to help you articulate your symptoms more clearly.

Man pouring capsule onto his palms
Image by rawpixel.com

I’m Not Taking My Medication As Prescribed

Taking medications as prescribed is crucial for managing chronic conditions and preventing complications. Your doctor may need to adjust your medication regimen if you’re not taking your medications as prescribed. They can also provide you with resources to help you remember to take your medications, manage side effects, or reduce costs.

Barriers around medication use are common for many patients. Some reasons why patients don’t take their medications as prescribed include forgetting, side effects, cost, and misunderstanding the instructions. It’s important to be honest with your doctor about any challenges you’re facing with your medication regimen.

How to Talk to Your Doctor About Medication Adherence

Be open and honest with your doctor about any challenges you’re facing with your medication regimen. Your doctor can provide you with resources and support to help you manage your medications. Consider asking for a medication review to ensure that you’re taking the right medications at the right times.

I’m Struggling To Make Lifestyle Changes

Lifestyle changes, like eating a healthy diet, getting regular exercise, and quitting smoking, can have a significant impact on your health. These changes can help ease symptoms, possibly prevent additional chronic conditions, and improve your overall quality of life.

It’s important to understand the benefits of lifestyle changes and how they can improve your health. Your doctor can provide you with resources and support to make these changes, including referrals to a nutritionist, exercise physiologist, or smoking cessation program.

Overcoming Barriers to Making Lifestyle Changes

Making lifestyle changes can be challenging, but there are strategies that can help. These can include breaking down your goals into smaller, achievable steps, finding a support system, and tracking your progress. Work with your doctor to find the best strategies that work for you and your lifestyle.

A transgender woman in a hospital gown speaking to her doctor (who is a transgender man) in an exam room
The Gender Spectrum Collection

I Need More Information About My Diagnosis

Knowing about your diagnosis can help you make informed decisions about your health and treatment options. It can also help you understand what to expect in terms of symptoms and potential complications. Additionally, understanding your diagnosis can help you communicate more effectively with your doctor and other healthcare professionals.

Being diagnosed with a health condition can be overwhelming and confusing. It’s important to take the time to understand what your diagnosis means, what the symptoms are, and what treatment options are available. However, doctors may not always have the time to provide a complete explanation during office visits. That’s why it’s important to speak up if you need more information about your diagnosis.

Asking the Right Questions to Your Doctor About Your Diagnosis

If you need more information about your diagnosis, it’s important to ask your doctor the right questions. Some good questions to ask include: What caused my condition? What are the symptoms and how can I manage them? What are my treatment options? What are the potential risks and benefits of each treatment option? By asking these questions, you can gain a better understanding of your diagnosis and what you can do to manage it.

I Don’t Feel Like My Treatment Plan Is Working

When you’re diagnosed with a health condition, your doctor will likely create a treatment plan to manage your symptoms and improve your overall health. However, not all treatment plans work for everyone. If you don’t feel like your treatment plan is working, it’s important to speak up.

Some signs that your treatment plan may not be working include: Your symptoms aren’t improving or are getting worse; you’re experiencing side effects from your medication; or your condition is interfering with your daily life. If you’re experiencing any of these symptoms, it’s important to talk to your doctor.

If you don’t agree with your doctor’s treatment plan, it’s important to speak up and ask questions. Your doctor should be willing to work with you to find a treatment plan that you feel comfortable with. If you still don’t feel comfortable with the treatment plan after discussion, don’t be afraid to seek a second opinion.

How to Talk to Your Doctor About Treatment Plan Alternatives

If you don’t feel like your treatment plan is working, it’s important to discuss alternative options with your doctor. Some alternative treatment options may include switching medications, adjusting the dosage of your medication, or trying alternative therapies like acupuncture or physical therapy. By discussing these options with your doctor, you can work together to find a treatment plan that works for you.

PS: I pulled together worksheets that can help you evaluate chronic pain treatment and medication changes.

I’m Experiencing Side Effects From My Medication

Medications can be an effective way to manage symptoms and improve your health. However, like all medications, they can come with side effects. It’s important to understand the potential side effects of any medication you’re taking.

If you’re experiencing side effects from your medication, it’s important to report them to your doctor. Your doctor can help you understand whether the side effects are normal or require further attention. They can also help you determine whether you need to adjust your medication dosage or switch to a different medication.

Discussing Medication Alternatives and Adjustments with Your Doctor

If you’re experiencing side effects from your medication, it’s important to discuss alternative treatment options with your doctor. They may be able to adjust your medication dosage or switch you to a different medication. By discussing these options with your doctor, you can find a treatment plan that effectively manages your symptoms without causing unwanted side effects.

woman with fog around her head
Image by rawpixel.com

I’m Concerned About My Mental Health

It’s important to remember that mental health is just as important as physical health. There’s no shame in seeking help for mental health concerns. In fact, talking about your mental health can help reduce stigma and encourage others to seek help.

Mental health problems can manifest in many different ways, including changes in mood, behavior, and cognition. Common symptoms of mental health problems include feeling sad, anxious, irritable or angry, changes in appetite or sleep patterns, and difficulty concentrating. If you notice any changes in your mental health, it’s important to talk to your doctor.

Talking Mental Health with Your Doctor

Your doctor can provide you with resources and referrals for mental health care. This can include therapy, medication, or both. It’s important to be open and honest with your doctor about your mental health concerns, so they can provide you with the best care and support.

I’m Feeling Anxious or Depressed

Mental health is just as important as physical health. If you’re feeling anxious or depressed, it’s important to seek help.

Symptoms of anxiety and depression can include difficulty sleeping, loss of appetite, feelings of hopelessness or helplessness, and trouble concentrating. If you’re experiencing any of these symptoms, it’s important to talk to your doctor.

Talking Mental Health with Your Doctor

If you’re feeling anxious or depressed, it’s important to talk to your doctor. They can help you determine whether you need additional support, such as therapy or medication. By seeking help for your mental health concerns, you can improve your overall well-being and quality of life.

What If I’m Uncomfortable With My Doctor?

If you don’t feel comfortable with your current doctor, it’s important to remember that you have the right to seek out a new healthcare provider. Look for someone who is attentive to your needs, communicates clearly, and makes you feel heard and understood.

If you feel that your doctor isn’t taking your concerns seriously, it’s important to speak up and advocate for yourself. Be clear and direct about your concerns, and provide as much detail as possible to help your doctor understand your perspective.

Takeaway

By being open and honest with your doctor, you can work together to create an effective treatment plan that addresses your unique health needs. Remember to advocate for yourself, ask questions, and communicate any concerns you may have. Your doctor is there to help you, but they need your help in order to provide the best possible care. With these things in mind, you can build a strong partnership with your doctor and take control of your health.

SJIA Interstitial Lung Disease

Posted on by Grayson

A new journal article details the cases of nine patients dealing with SJIA-related interstitial lung disease (ILD).

You can read the full journal article below.

Jade Tam-Williams, Chandra Swanson, Ashley Cooper, et al. Pediatric Systemic Juvenile Idiopathic Arthritis related Lung Disease: Description of clinical cohort and review of management. Authorea. May 18, 2023. DOI: 10.22541/au.168443465.51905327/v1

First-line use of biologics may lead to favorable outcomes in sJIA

Posted on by Grayson

The following is an article released May 15, 2023, by Contemporary Pediatrics:

A study in patients with new-onset systemic juvenile idiopathic arthritis (sJIA) found most patients treated with biologics had desirable short-term clinical outcomes combined with decreased use of glucocorticoids (GCs).

The 73 patients in the study, who were enrolled at numerous sites, were aged 6 months to 18 years at disease onset and had a fever for at least 2 weeks, arthritis in 1 or more joints for at least 10 days, a rash, and generalized lymphadenopathy, among other symptoms, and had received initial treatment with biologics or nonbiologic GCs. Participants were treated according to 1 of 4 plans chosen by their physicians, which included 2 biologics (interleukin [IL]-1i and IL-6i, both with or without GC) and 2 nonbiologics (methotrexate with or without GC and GC alone); 63 patients (86%) were enrolled in the biologic treatments and 10 (14%) in the nonbiologics. Investigators collected clinical data at baseline and 2 weeks as well as at 1, 3, 6, 9, and 12 months following enrollment.

In choosing a treatment plan, many health care providers reported that they initiate treatment of sJIA with a biologic agent most of the time. They said this is because of the likelihood of the biologic’s effectiveness for systemic features, minimizing systemic glucocorticoids, and the possibility of effectiveness for arthritis. Of the 10 clinical sites that enrolled 3 or more patients, 8 sites assigned all their patients to the biologics.

At 9 months, 57% of patients achieved the primary outcome of clinical inactive disease (CID) without current GC use and 75% had a clinical juvenile arthritis disease activity score at or below 2.5 with no fever and no current GC use. Patients in the biologic and nonbiologic groups had similar outcomes, but 4 of the 6 patients evaluated for CID in the nonbiologic group had initiated biologics during the study. Outcomes at 12 months were similar to those at 9 months. Of the patients receiving biologics who subsequently started methotrexate, 1 of 6 had CID without concurrent GC use at 9 months.

Beukelman T, Tomlinson G, Nigrovic PA, et al. First-line options for systemic juvenile idiopathic arthritis treatment: an observational study of Childhood Arthritis and Rheumatology Research Alliance consensus treatment plans. Pediatr Rheumatol Online J. 2022;20(1):113. doi:10.1186/s12969-022-00768-6

If you want to read the full journal article cited above, you can do so here.

Outcomes of Biologic Agent Switching Studied in JIA

Posted on by Grayson

The following is an article released by Rheumatology Advisor:

Switching between biologic agents is common among patients with juvenile idiopathic arthritis (JIA), with inadequate response being the most reason for the switch, according to study results published in Journal of Clinical Rheumatology.

Participants were aged 18 years and younger and were diagnosed with JIA before the age of 16 years. The diagnosis was consistent with the International League of Rheumatology Societies criteria. In addition, eligible participants received treatment with more than 1 biologic agent between January 2009 and 2022.

The study authors concluded that clinicians and researchers should be alert to the need for patients undergoing JIA treatment to change protocols. They noted, “[A total of 25%] of patients undergoing biological drug treatment may require biological agent switching.”

You can read the full article here.

Research links immune cell receptors to asthma, inflammatory lung disease

Posted on by Grayson

The following is from the Cleveland Clinic as posted on Medical Express:

Researchers discovered a new way a protein called MCEMP1 contributes to severe inflammation in the airway and lungs. The discovery, published in Nature Communications, provides critical information for developing therapeutic interventions to treat long-term lung conditions, including asthma, on a biological level.

The study was conducted in a lab led by Jae Jung, Ph.D., chair of the Cancer Biology Department, director of the Infection Biology program, and director of the Sheikha Fatima bint Mubarak Global Center for Pathogen & Human Health Research.

Severe asthma is caused by airway inflammation in response to a trigger, like allergens or air pollution. The inflammation causes the airway to swell up and become narrower and stiffer, which makes breathing difficult. Asthma currently affects more than 25 million people in the U.S and 300 million people worldwide.

Inflammation is part of innate immune response, or the process the body uses to summon immune cells to combat pathogens. Inhalers treat the inflammation in the airway, but do not address the underlying biological causes of the recurring inflammation.

Mast cells release histamines and elicit other immune responses that cause allergic inflammation, so researchers examined what proteins on that cell are critical to prompting a severe immune response.

So, what is MCEMP1?

MCEMP1 is a surface-level protein on mast cells. Previous research implicated MCEMP1 in multiple inflammatory lung diseases in addition to asthma, including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

When MCEMP1 expression was eliminated on the surface of the mast cell, researchers saw reduced airway inflammation and lung damage. The study showed that MCEMP1 was associated with elevated mast cell numbers. Researchers observed higher rates of inflammation and lung function defect when MCEMP1 was expressed on mast cells.

MCEMP1 is expressed highly in lung cells, but its expression is induced during immune response in other parts of the body as well. That shows the value in searching for MCEMP1 function in other parts of the body, Dr. Choi says.

“Understanding how this mechanism works in the lung not only provides us with a path to new therapies for asthma, but it could be a finding that helps us map out similar functions in other inflammatory diseases in the lung and throughout the body,” she says.

You can read the full open-access journal article on Nature.

Disparities Contribute to Delays in Care and Unfavorable Disease Outcomes in pJIA

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Although health disparities are prevalent in many chronic diseases, including rheumatic diseases like rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), they remain poorly understood in pediatric rheumatology.

Two analyses conducted by the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry have highlighted important disparities among children with polyarticular juvenile idiopathic arthritis (pJIA).

Read more.

FDA approves 20-valent pneumococcal conjugate vaccine for infants 6 weeks and older

Posted on by Grayson

The following is a press release issued by Pfizer on April 27, 2023. I am sharing this to help spread the word and have not been asked or incentivized to do so by Pfizer.

The U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®(20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.

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